EN ISO 5366:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for TRACHEOSTOMY TUBES
  and connectors
5 Materials
6 Design requirements for TRACHEOSTOMY TUBES
  and connectors
7 Requirements for TRACHEOSTOMY TUBES supplied sterile
8 Information supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security of
        attachment of a fitted connector and NECK-PLATE
        TO THE TRACHEOSTOMY TUBE
Annex C (normative) - Test method for determining the
        diameter of the CUFF
Annex D (normative) - Test method for cuff herniation
Annex E (normative) - Test method for determining kink
        resistance
Annex F (informative) - Guidance on materials and design
Annex G (informative) - Hazard identification for
        risk assessment
Bibliography

ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support.ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases.Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard.NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.